Nevirapine
Pronunciation: ne-VYE-ra-peen.
- Generic name
- nevirapine
- Drug class
- Non-nucleoside reverse transcriptase inhibitor (NNRTI) -- antiretroviral for HIV-1
- Form
- Tablet, extended/prolonged-release tablet, and oral suspension (commonly 200 mg tablets, 400 mg extended-release tablets, and 50 mg/5 mL oral suspension)
- Route
- Oral
- Legal status
- Prescription-only in all markets reviewed
Availability and supply rules vary by country
Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand
Australia: Viramune; Viramune XR (5) · Full directory
Boxed warning: Life-threatening liver injury (hepatotoxicity) and severe, life-threatening skin reactions
Nevirapine carries a boxed warning (the US FDA's strongest safety warning) with two distinct parts. Hepatotoxicity: severe, life-threatening, and in some cases fatal liver injury has occurred with nevirapine, particularly in the first 18 weeks of treatment; the risk of any symptomatic liver event, regardless of severity, is greatest in the first 6 weeks. This risk is substantially higher in adult women with a CD4+ cell count above 250 cells/mm3 at the start of treatment (about a 12-fold higher risk of a symptomatic liver event compared with women with lower CD4+ counts) and, similarly, in adult men with a CD4+ cell count above 400 cells/mm3. Liver blood tests must be monitored before starting and throughout treatment, especially in the first 18 weeks. Severe skin reactions: severe, life-threatening, and sometimes fatal skin reactions have occurred with nevirapine, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions with rash, fever or other whole-body symptoms, and organ dysfunction (including liver failure). These reactions occur most often in the first 6 weeks of treatment. Anyone who develops signs of a severe skin reaction or hypersensitivity reaction must have nevirapine stopped by their treating clinician and get immediate medical evaluation; anyone who develops a rash in the first 18 weeks of treatment needs liver blood tests checked right away. (1) (3)
What nevirapine is and how it works
Nevirapine is a prescription antiretroviral medicine used, always together with at least two other antiretroviral medicines, to treat HIV-1 infection. It belongs to a class called NNRTIs (non-nucleoside reverse transcriptase inhibitors), which block an enzyme HIV needs to copy itself. (1)
Nevirapine carries two genuine, serious boxed warnings: a real risk of life-threatening liver injury, and a real risk of severe, sometimes life-threatening skin reactions (including Stevens-Johnson syndrome). Both risks are highest in the first 6 to 18 weeks of treatment, which is why treatment always starts at a lower dose for the first 14 days and why regular liver blood tests and close monitoring for rash are part of safe treatment from the very first dose.
Mechanism of action: how nevirapine works
Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI). It binds directly to HIV-1 reverse transcriptase and blocks the RNA- and DNA-dependent DNA polymerase activities of the enzyme, disrupting the catalytic site needed for viral replication. It is not active against HIV-2. Resistant virus emerges rapidly if nevirapine is used as monotherapy, so it must always be combined with other antiretroviral agents. (1) (3)
What nevirapine is used for
HIV-1 infection (combination antiretroviral therapy)
Used together with at least two other antiretroviral medicines to treat HIV-1 infection in adults and children (age range for paediatric use varies slightly by country, from over 15 days old in the US source to over 2 months old in the New Zealand source, and 'children of any age' in the UK source reviewed). Nevirapine must never be used alone (as monotherapy), since resistant virus can develop rapidly. (1) (2) (6)
Before taking nevirapine
Do not take / not appropriate for
- Do not take nevirapine if you have moderate or severe liver impairment (Child-Pugh Class B or C). (all countries) (1) (3)
- Do not take nevirapine if you previously had to stop it because of a severe rash, hypersensitivity reaction, or liver reaction linked to nevirapine. (United States) (1)
- Do not take nevirapine as your only HIV medicine -- it must always be combined with at least two other antiretroviral medicines. (all countries) (6)
- Discuss with your prescriber before starting nevirapine if you are an adult woman with a CD4+ count above 250 cells/mm3, or an adult man with a CD4+ count above 400 cells/mm3 -- nevirapine is generally avoided in these situations unless your prescriber judges the benefit clearly outweighs the substantially higher liver-injury risk. (all countries) (1) (3)
Tell your clinician about
- Any history of liver disease, hepatitis B or C, or abnormal liver blood tests.
- Your current CD4+ cell count, since this affects your starting risk of liver injury.
- All other medicines, especially rifampin/rifampicin, hormonal contraceptives, and other HIV medicines (particularly protease inhibitors).
- Whether you are pregnant, plan to become pregnant, or are breastfeeding.
- Any previous allergic reaction or severe rash with nevirapine or other antiretroviral medicines.
How to take nevirapine
- Always taken together with at least two other antiretroviral medicines, exactly as your prescriber directs.
- Treatment starts with a lower once-daily dose for the first 14 days (the 'lead-in period'), which has been shown to reduce the frequency of rash, before increasing to the full twice-daily dose.
- If treatment is interrupted for more than 7 days, the 14-day lead-in period must be restarted under your prescriber's direction before returning to the full dose.
- Extended-release tablets must be swallowed whole -- do not chew, crush, or divide them.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)
Missed dose
Contact your prescriber or HIV care team for guidance if you miss a dose, especially during the 14-day lead-in period -- do not double a dose or change your schedule on your own, since correct timing is part of how this medicine's risks are managed safely.
Overdose
Seek urgent medical attention if you think too much nevirapine has been taken, or if you develop any signs of a severe skin reaction, jaundice (yellowing of the skin or eyes), or severe illness. (1)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms.
Rash (most common in the first 6 weeks of treatment, during the lead-in period).
What to notice: Rash (most common in the first 6 weeks of treatment, during the lead-in period).
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Nausea.
What to notice: Nausea.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Headache.
What to notice: Headache.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Fatigue.
What to notice: Fatigue.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Abnormal liver blood test results.
What to notice: Abnormal liver blood test results.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Serious warnings
Signs of serious liver injury — boxed_warning
Symptoms: Yellowing of the skin or eyes (jaundice), dark urine, unusual tiredness, loss of appetite, nausea, or pain in the upper right side of the abdomen.
Action: Contact your clinician immediately and have liver blood tests checked -- nevirapine can cause severe, life-threatening liver injury, especially in the first 18 weeks of treatment. This risk is substantially higher in women with a CD4+ count above 250 cells/mm3 and men with a CD4+ count above 400 cells/mm3 at the start of treatment. (1) (3)
Signs of a severe skin reaction or hypersensitivity reaction — boxed_warning
Symptoms: A widespread or blistering rash, peeling skin, sores in the mouth or eyes, fever, swollen glands, or feeling generally unwell -- most common in the first 6 weeks of treatment.
Action: Seek emergency medical help immediately and have nevirapine stopped under your clinician's direction. This is a rare but serious and sometimes fatal reaction (including Stevens-Johnson syndrome and toxic epidermal necrolysis); anyone who develops a rash in the first 18 weeks of treatment needs liver blood tests checked right away too. (1) (3)
Signs of a general allergic/hypersensitivity reaction affecting other organs — emergency
Symptoms: Rash together with fever, general malaise, extreme tiredness, muscle or joint aches, blisters, mouth sores, swelling of the face, or signs of organ problems (such as liver or kidney issues).
Action: Seek emergency medical help immediately -- this can be part of the same hypersensitivity syndrome as the boxed skin-reaction warning above and needs urgent assessment. (1)
Interactions
- Rifampin/rifampicin (a tuberculosis antibiotic): should not be given together with nevirapine, since it substantially reduces nevirapine levels and effectiveness. (1) (3)
- Hormonal contraceptives (such as ethinyl estradiol/norethindrone-containing pills): nevirapine can lower their blood levels and effectiveness; an additional or alternative non-hormonal contraceptive method is recommended. (1) (3)
- Certain other HIV medicines, especially protease inhibitors (such as atazanavir, indinavir, and lopinavir): substantial interactions exist, and dose adjustments are often needed -- your HIV specialist will manage your full combination regimen. (1) (3)
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
No increased risk of birth defects has been observed in the data reviewed in the US source, but severe, sometimes fatal liver events have been reported in pregnant women taking nevirapine -- treatment during pregnancy is managed closely by your HIV specialist, weighing these risks against the benefits of treatment. (1) (2) (3) (4) (5) (6)
Breastfeeding
Guidance genuinely differs by context. The US source reviewed instructs against breastfeeding while taking Viramune, consistent with standard high-resource-setting HIV guidance to prevent transmission through breast milk. The EU source reviewed notes that breastfeeding recommendations follow World Health Organization guidance, which in some resource-limited settings supports continuing maternal antiretroviral therapy during breastfeeding. Follow your own HIV specialist's guidance for your specific situation and setting. (1) (2) (3) (4) (5) (6)
Children
Used in children from as young as over 15 days old (US source) or over 2 months old (New Zealand source), always in combination with other antiretroviral medicines and with individually calculated, specialist-directed dosing based on body surface area or weight. (1) (2) (3) (4) (5) (6)
Elderly
No specific dose adjustment based on age alone is described in the sources reviewed. (1) (2) (3) (4) (5) (6)
Hepatic_impairment
Contraindicated in moderate or severe liver impairment (Child-Pugh Class B or C); liver function is monitored closely throughout treatment given the boxed hepatotoxicity warning. (1) (2) (3) (4) (5) (6)
Renal_impairment
Not specifically detailed with a dose adjustment in the sources reviewed; discuss with your HIV specialist if you have kidney problems. (1) (2) (3) (4) (5) (6)
Source_ids
US-DAILYMED-VIRAMUNE-2026,EU-EMA-VIRAMUNE-EPAR-2026 (1) (2) (3) (4) (5) (6)
Monitoring
Before starting
- Baseline liver function tests
- Current CD4+ cell count
- Review of other medicines for interactions (rifampin/rifampicin, hormonal contraceptives, protease inhibitors)
During treatment
- Liver function tests at baseline, before dose escalation, and at regular intervals during the first 18 weeks (specific schedules vary slightly by source, generally every 2-3 weeks for the first 1-3 months, then monthly).
- Close monitoring for rash or other skin changes, especially during the first 6 weeks.
- Immediate liver function testing if a rash develops in the first 18 weeks of treatment.
- Ongoing clinical monitoring for signs of hypersensitivity syndrome (fever, malaise, organ involvement) alongside any skin changes.
Storage
Store at room temperature, protected from moisture and light, out of reach of children.
Professional information
Clinician-facing context only, sourced from the current US FDA prescribing information and the EMA's centralised Viramune EPAR reviewed for this dossier; verify against the current full label before prescribing.
United States / United Kingdom / European Union / Canada
Indication: HIV-1 infection (combination antiretroviral therapy)
Dose summary: Adults: 200 mg once daily for 14 days (lead-in), then 200 mg twice daily, max 400 mg/day. Paediatric (US, >15 days old): 150 mg/m2 once daily for 14 days, then 150 mg/m2 twice daily, max 400 mg/day. Restart the 14-day lead-in if therapy is interrupted >7 days.
Renal context: Not specifically detailed with a dose adjustment in the sources reviewed. (1) (3)
New Zealand
Indication: HIV-1 infection, adults and children over 2 months
Dose summary: Same 14-day lead-in principle as other markets; always combined with at least two other antiretroviral agents; paediatric dosing individually calculated.
Renal context: Not specifically detailed with a dose adjustment in the source reviewed. (6)
Hepatic guidance
Contraindicated in moderate-to-severe hepatic impairment (Child-Pugh Class B or C); hepatotoxicity is a boxed-warning-level risk requiring scheduled liver function monitoring throughout treatment, especially the first 18 weeks.
Overdose note
Managed with supportive care; no specific antidote described in the sources reviewed; monitor closely for hepatic and skin/hypersensitivity reactions. (1) (3)
Frequently asked questions
Is nevirapine available in the US, UK, Europe, Canada, Australia, and New Zealand?
Yes. It is authorised in all six regions, as Viramune and Viramune XR (extended-release) in the US, UK, Canada, Australia, and New Zealand (also as Nevirapine Viatris in New Zealand), and as Viramune under a genuine EU-wide centralised marketing authorisation across the European Union. (1) (2) (3) (4) (5) (6)
Why does nevirapine have two boxed warnings?
Because it carries two separate, genuine, serious risks confirmed by regulators: severe, sometimes fatal liver injury (highest risk in the first 18 weeks, and substantially higher in women with a CD4+ count above 250 cells/mm3 or men above 400 cells/mm3), and severe, sometimes fatal skin reactions including Stevens-Johnson syndrome (highest risk in the first 6 weeks). This is why treatment starts with a lower dose for 14 days and includes close monitoring with liver blood tests from the very first dose. (1)
Why does nevirapine treatment start at a lower dose for the first 2 weeks?
This 14-day 'lead-in' period (a lower, once-daily dose before increasing to the full twice-daily dose) has been shown to reduce how often rash occurs. If treatment is interrupted for more than 7 days, your prescriber will restart this lead-in period before returning to the full dose. (1) (2)
What is the mechanism of action of nevirapine?
Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI). It binds directly to HIV-1 reverse transcriptase and blocks the RNA- and DNA-dependent DNA polymerase activities of the enzyme, disrupting the catalytic site needed for viral replication. It is not active against HIV-2. Resistant virus emerges rapidly if nevirapine is used as monotherapy, so it must always be combined with other antiretroviral agents. (1) (3)
References
- VIRAMUNE (nevirapine) tablet -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, Boehringer Ingelheim · United States · dated 2026-01-01 · accessed 2026-07-30 · source 1
- Nevirapine 200mg Tablets -- Summary of Product Characteristics (SmPC)electronic medicines compendium (emc), United Kingdom -- Summary of Product Characteristics · United Kingdom · dated 2025-01-01 · accessed 2026-07-30 · source 2
- Viramune (nevirapine) -- EPAR product information (Summary of Product Characteristics)European Medicines Agency (EMA) -- centralised European Public Assessment Report (EPAR) and product information · European Union · dated 2026-01-01 · accessed 2026-07-30 · source 3
- VIRAMUNE (nevirapine) -- Product MonographHealth Canada -- Product Monograph (Viramune, nevirapine) · Canada · dated 2020-01-01 · accessed 2026-07-30 · source 4
- VIRAMUNE / VIRAMUNE XR (nevirapine) -- ARTG entries 72099 and 176980Therapeutic Goods Administration (TGA), Australia -- Australian Register of Therapeutic Goods (ARTG) and PBS · Australia · dated 2026-04-01 · accessed 2026-07-30 · source 5
- Viramune (nevirapine) tablets and oral suspension -- New Zealand Data SheetMedsafe (New Zealand Medicines and Medical Devices Safety Authority) -- New Zealand Data Sheet · New Zealand · dated 2025-01-01 · accessed 2026-07-30 · source 6
Brand names by country
Single-ingredient nevirapine names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- Viramune; Viramune XR; generic nevirapine (1)FDA approved currently labeled · 200 mg tablets, 400 mg extended-release tablets, 50 mg/5 mL oral suspension · Boehringer Ingelheim (brand); multiple generic manufacturers
United Kingdom
- Nevirapine (generic); Viramune oral suspension (2)emc current smpc confirmed · 200 mg tablets, 400 mg prolonged-release tablets, 50 mg/5 mL oral suspension · Multiple manufacturers listed on emc
Canada
- VIRAMUNE
- VIRAMUNE XR
- APO-NEVIRAPINE XR
Australia
- Viramune; Viramune XR (5)tga artg registered confirmed · 50 mg/5 mL oral suspension, 400 mg extended-release tablets · Boehringer Ingelheim Pty Ltd
New Zealand
- Viramune; Nevirapine Viatris (previously Alphapharm) (6)medsafe data sheet confirmed · 200 mg tablets, 50 mg/5 mL oral suspension · Boehringer Ingelheim; Viatris (generic)
View brands in additional countries.
European Union
Viramune (3)